Translation
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`Launch of the Anti-Cancer Agent “Kadcyla®”
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`April 17, 2014 (Tokyo) – Chugai Pharmaceutical Co., Ltd. [Main Office: Chuo-ku, Tokyo.
`Chairman & CEO: Osamu Nagayama (hereafter, “Chugai”)] announced today that it will launch
`the anti-HER2 antibody-tubulin polymerization inhibitor conjugate “Kadcyla® Intravenous Infusion
`100 mg and 160 mg” [generic name: trastuzumab emtansine (genetic recombinant)] (hereafter,
`Kadcyla®) for the indication of “HER2-positive inoperable or recurrent breast cancer” on April 18,
`2014. Kadcyla® received a manufacturing and marketing approval on September 20, 2013 and
`was listed on the National Health Insurance (NHI) reimbursement price list on April 17, 2014.
`
`Kadcyla® is a recombinant humanized monoclonal antibody developed by F. Hoffmann-La
`Roche Ltd. [Head Office: Basel, Switzerland. CEO: Severin Schwan] (hereafter, Roche), a global
`pioneer and leader in Personalised Healthcare. Kadcyla® is an antibody drug conjugate,
`comprising the anit-HER2 humanized monoclonal antibody, trastuzumab, and a cytotoxic tubulin
`polymerization inhibitor, DM1, attached together using a stable linker. Kadcyla® is designed to
`target HER2, thereby inhibiting HER2 signaling and inducing antibody-dependent cell mediated
`cytotoxicity, and at the same time the tubulin polymerization inhibitor DM1 is directly delivered
`inside the HER2-positive cancer cells to destroy them.
`Kadcyla® was approved for patients with previously treated, HER2-positive metastatic breast
`cancer in the US in February 2013 and in Europe in November 2013.
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`The number of patients newly diagnosed with breast cancer in Japan continues to rise each year
`and is estimated to become, on annual average, approximately 60,000 during 2015-2019*. And
`HER2 expression has been observed in approximately 20% of breast cancer patients.
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`Following the approval of Kadcyla® in September 2013, in order to provide access to patients,
`Chugai initiated a clinical study at a limited number of medical institutions from January 2014.
`The purpose of the study was to accumulate Japanese clinical data. Since enrollment has
`reached the target number and access will be normalized after launch, this study will be
`terminated and the data will be compiled.
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`As the top pharmaceutical company in the field of oncology in Japan, Chugai is convinced that
`Kadcyla® can contribute to the treatment of patients with “HER2-positive inoperable or recurrent
`breast cancer” by providing a new therapeutic option and will promote appropriate use of
`Kadcyla®.
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` *
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` T. Sobue, et al., Cancer White Paper 2012, Shinoharashinsha Inc.
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`IMMUNOGEN 2266, pg. 1
`Phigenix v. Immunogen
`IPR2014-00676
`
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`Kadcyla® Intravenous Infusion 100 mg
`Kadcyla® Intravenous Infusion 160 mg
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`Drug Information
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`Brand name:
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`Generic name:
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`Indications:
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`Dosage and administration: The usual adult dosage is 3.6 mg/kg (body weight) of trastuzumab
`emtansine (genetical recombination) every three weeks given by
`intravenous infusion.
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`trastuzumab emtansine (genetical recombination)
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`HER2-positive inoperable or recurrent breast cancer
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`September 20, 2013
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`April 18, 2014
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`Date of approval:
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`Date of listing in the NHI reimbursement price: April 17, 2014
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`Date of launch:
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`Shelf life:
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`Drug price:
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`Kadcyla® Intravenous Infusion 100 mg
`Kadcyla® Intravenous Infusion 160 mg
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`Kadcyla® Intravenous Infusion 100 mg/vial
`Kadcyla® Intravenous Infusion 160 mg/vial
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`2 years and 6 months
`3 years
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`235,108 yen
`373,945 yen
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`Kadcyla ® is a registered trademark of F. Hoffmann-La Roche, Ltd.
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`Package photo
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`IMMUNOGEN 2266, pg. 2
`Phigenix v. Immunogen
`IPR2014-00676